Senate Confirms Scott Gottlieb to Lead FDA -- Update

By Joseph Walker and Thomas M. BurtonFeaturesDow Jones Newswires

The U.S. Senate voted Tuesday in a 57-42 mostly party-line vote to confirm Scott Gottlieb as the new commissioner of the Food and Drug Administration.

Dr. Gottlieb, 44, a veteran health-care investor and physician, is well known to many drug-industry executives. He worked for years as a consultant to companies including GlaxoSmithKline PLC and Vertex Pharmaceuticals Inc., spoke frequently at health-care and investor conferences, and wrote hundreds of essays and op-eds, often advocating for the FDA to approve drugs more quickly and loosen regulations on off-label marketing.

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He is also steeped in the details of regulatory approval of drugs and medical devices, having previously served as deputy FDA commissioner under the George W. Bush administration.

Dr. Gottlieb favors free-market strategies to bring down drug costs, including by increasing the rate of generic-drug approvals at the FDA. He has also questioned the wisdom of allowing U.S. consumers to import brand-name drugs from countries like Canada, where they cost less, in part because of safety concerns -- a viewpoint shared by drugmakers.

"He agrees with the basic concept of the pharmaceutical industry: the need to have drugs come to market quickly, viewing the bureaucracy as necessary but [it] can get in the way of innovation," said Ronny Gal, a stock analyst at Sanford C. Bernstein & Co.

Company officials say they expect Dr. Gottlieb to push the FDA to accelerate its adoption of more flexible approaches to evaluating new drugs and clinical trials. And his experience at the agency should help him garner support from rank-and-file staff to implement his agenda, executives say.

He "sounds like a progressive person who wants to get things done," Eli Lilly & Co. Chief Executive David Ricks said in an interview. "He's got experience in the agency already. He's a doctor and a cancer survivor. Sounds to me like he has a balanced perspective." Dr. Gottlieb had Hodgkin lymphoma and is cancer-free now.

His work in recent years as a venture capitalist, making hundreds of thousands of dollars from medical companies in consulting and speaking fees, had given pause to Democrats in the Senate.

Sen. Patty Murray (D., Wash.), the ranking Democrat on the Senate health committee, said she opposed Dr. Gottlieb because of his "unprecedented industry ties" and what she regards as his "inability to withstand industry pressure."

Dr. Gottlieb has said he would recuse himself for one year from FDA decisions on more than 20 companies where he has potential conflicts of interest. "I understand how important impartiality of this agency is," Dr. Gottlieb said at his Senate confirmation hearing in April. "I don't want to do anything in my conduct to reduce people's confidence in the agency's mission."

Dr. Gottlieb earned at least $645,000 from drug companies and trade groups from the beginning of 2016 through the first two months of 2017, according to his disclosure statements.

He served for seven years on a GlaxoSmithKline board that manages the company's research and development investments, providing "a valuable perspective on the U.S. health-care and payer environment," said a GSK spokeswoman. As FDA commissioner, Dr. Gottlieb "will help ensure that the FDA maintains its focus on innovation and protecting public health by expeditiously approving safe and effective new treatments for patients," she said.

Dr. Gottlieb has also been supportive of loosening FDA restrictions on off-label marketing, where companies advertise drug uses that haven't been cleared by the agency. He has advocated allowing companies to distribute such information to doctors as long as it is truthful and not misleading.

There are numerous alternatives to "FDA's current regime -- which virtually bans off-label promotion -- that would promote FDA's public health goals even better than the current regime does," Dr. Gottlieb wrote in expert testimony in 2015 on behalf of Amarin Corp., in a lawsuit the company filed against the FDA over its off-label marketing policies. Dr. Gottlieb was paid $600 per hour for his work on the case, he wrote in his testimony.

Like other of President Donald Trump's nominees, Dr. Gottlieb has been critical of the agency he is nominated to oversee. He wrote in a 2012 essay that the FDA has a "harmful culture" that mistrusts doctors to prescribe drugs appropriately, leading officials to have "an excessive desire for certainty" that new medicines are safe and effective before they are approved, he wrote.

The FDA has several methods for accelerating approvals, such as granting conditional approval if studies show the drug is "reasonably likely" to help patients live longer or have other benefits. Some FDA divisions have embraced the faster methods, but other divisions are still very "rigid," said Ron Cohen, chief executive of Acorda Therapeutics Inc. "Even if you bring them evidence of benefit to patients, it's still an uphill climb."

Dr. Gottlieb said in April that he would create "consistency to how different parts of the FDA" use their powers.

Some researchers question how much further the FDA can go in speeding up drug approvals without lowering its standards. More than two-thirds of drug approvals last year were completed under "priority review," where the FDA makes an approval decision within six months instead of the standard 10 months, according to the FDA.

"The FDA is already one of the fastest regulatory agencies in the world, " says Aaron Kesselheim, an associate professor of medicine at Harvard Medical School. "Faster for faster's sake is not wise."

--Peter Loftus contributed to this article.

Write to Joseph Walker at and Thomas M. Burton at

(END) Dow Jones Newswires

May 09, 2017 18:05 ET (22:05 GMT)